510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983918Substantially Equivalent

Radiolucent Cassette Limb Positioner (R-Clip)

Mastek, Inc., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983918 is the FDA 510(k) clearance record for RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP), a class II device, cleared for Mastek, Inc. on under FDA product code IXA (Cassette, Radiographic Film). FDA records list one 510(k) clearance for Mastek, Inc. As of , FDA records show no recalls naming K983918.

Clearance record

Decision date
Received
(128 days to decision)
Product code
IXA Cassette, Radiographic Film
Regulation
21 CFR 892.1850
Device class
Class II
Review panel
Radiology
Applicant
Mastek, Inc. 1200 Binz, Suite 1200, Houston TX
510(k) summary
Statement
Third party review
No

Clearances, product code IXA

Trailing 12 months

FDA records hold no clearances under product code IXA in the trailing twelve months.

FDA records show no clearances under product code IXA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IXA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260